amlodipine besylate

Generic: amlodipine besylate

Labeler: legacy pharmaceutical packaging, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler legacy pharmaceutical packaging, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
Legacy Pharmaceutical Packaging, LLC

Identifiers & Regulatory

Product NDC 68645-516
Product ID 68645-516_4c2152ce-6c88-d033-e063-6394a90a90ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077955
Listing Expiration 2027-12-31
Marketing Start 2016-07-01

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a inhibitors [moa] dihydropyridine calcium channel blocker [epc] dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68645516
Hyphenated Format 68645-516

Supplemental Identifiers

RxCUI
197361 308135
UPC
0368645515540 0368645516547
UNII
864V2Q084H

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amlodipine besylate (source: ndc)
Generic Name amlodipine besylate (source: ndc)
Application Number ANDA077955 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68645-516-54)
source: ndc

Packages (1)

68645-516-54 30 TABLET in 1 BOTTLE (68645-516-54)

Ingredients (1)

amlodipine besylate (10 mg/1)

Linked Drug Pages (1)

Amlodipine Besylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c2152ce-6c88-d033-e063-6394a90a90ab", "openfda": {"upc": ["0368645515540", "0368645516547"], "unii": ["864V2Q084H"], "rxcui": ["197361", "308135"], "spl_set_id": ["2cdd0da9-eea6-45e0-b0b7-35413a168a4f"], "manufacturer_name": ["Legacy Pharmaceutical Packaging, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68645-516-54)", "package_ndc": "68645-516-54", "marketing_start_date": "20160701"}], "brand_name": "Amlodipine Besylate", "product_id": "68645-516_4c2152ce-6c88-d033-e063-6394a90a90ab", "dosage_form": "TABLET", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "68645-516", "generic_name": "Amlodipine Besylate", "labeler_name": "Legacy Pharmaceutical Packaging, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA077955", "marketing_category": "ANDA", "marketing_start_date": "20160701", "listing_expiration_date": "20271231"}